Ophthalmic device

ABSTRACT

An ophthalmic device including a cannula having a cannula distal end, a lumen, and one or more orifices coupled to the lumen is provided. The cannula is configured to deliver a fluid. A sleeve is disposed around the cannula and has a sleeve distal end. A handle is coupled to the sleeve and the cannula, the handle having an actuator. An internal mechanism is coupled to the actuator and configured to retract the sleeve relative to the cannula. The internal mechanism includes a follower fixedly coupled to the sleeve and moveable between distal and proximal positions, and a release member movable between an activated position and a release position. The release member is coupled to the actuator and configured to release a force that urges the follower from the distal position to the proximal position when the release member moves from the activated position to the release position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority toInternational Patent Application No. PCT/US2019/056482, filed Oct. 16,2019, which claims the benefit of priority under 35 U.S.C. § 119 fromU.S. Provisional Application No. 62/750,151, entitled “OPHTHALMICDEVICE,” filed Oct. 24, 2018, the entirety of which are incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure generally relates to medical devices andprocedures, and more particularly, to an ophthalmic device.

BACKGROUND

Glaucoma is a disease resulting from an increase in intraocular eyepressure (TOP). IOP may increase when natural drainage of the eye (e.g.,drainage of the humus of the eye) is prevented, reduced, or otherwiseblocked. Cavities in front of (e.g., on top of) the lens of the eye arefilled with a viscous fluid called aqueous humor. A continuous flow ofaqueous humor through the eye provides nutrition to portions of the eye(e.g., the cornea and the lens) that have no blood vessels. This flow ofaqueous humor also removes waste (e.g., foreign object debris) fromthese tissues. In a healthy eye, a stream of aqueous humor drains out ofthe anterior chamber of the eye through the trabecular meshwork and intoSchlemm's canal as new aqueous humor is secreted by the epithelial cellsof the ciliary body. The drained aqueous humor enters the venous bloodstream from Schlemm's canal and is carried along with the venous bloodleaving the eye. When the natural drainage mechanisms of the eye (e.g.,Schlemm's canal and/or the trabecular meshwork) stop functioningproperly, the IOP begins to increase.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary aspects of the presentdisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIG. 1 is a perspective view showing an example of an ophthalmic device.

FIGS. 2A-2B are perspective views showing a distal end of an example ofan ophthalmic device that has an inner cannula surrounded by a sleeve.FIG. 2A shows the inner cannula covered by the sleeve and FIG. 2B showsinner cannula protruding from the sleeve.

FIGS. 3A-3B are longitudinal section views showing a retractable sleeveinteracting with ocular tissue. FIG. 3A shows the sleeve in a distalposition and FIG. 3B shows the sleeve in a retracted proximal position.

FIGS. 4A-4B are side views showing examples of sleeves interacting withocular tissue. FIG. 4A shows an example of a sleeve sized to abutagainst a trabecular meshwork over a Schlemm's canal and a more rigidanatomy neighboring the Schlemm's canal. FIG. 4B shows an example of asleeve sized to collapse the trabecular meshwork into the Schlemm'scanal.

FIGS. 5A-5C are various views showing an example of a sleeve that can beincluded in an ophthalmic device. FIG. 5A is a perspective view of thesleeve, FIG. 5B is a top view of the sleeve, and FIG. 5C is a side viewof the sleeve.

FIGS. 6A-6C are various views showing an example of a sleeve that can beincluded in an ophthalmic device. FIG. 6A is a perspective view of thesleeve, FIG. 6B is a top view of the sleeve, and FIG. 6C is a side viewof the sleeve.

FIGS. 7A-7C are various views of an example of a cannula that can beincluded in an ophthalmic device. FIG. 7A is a perspective view ofcannula, FIG. 7B is a top view of the cannula as implemented in FIG. 7A,and FIG. 7C is a side view of cannula as implemented in FIG. 7A.

FIG. 8 is a longitudinal section view showing an example of a sleevethat can be included in an ophthalmic device.

FIGS. 9A-9C are side views showing an example of a mechanism that can beconfigured to retract a sleeve in an ophthalmic device. FIG. 9A showsthe mechanism in a starting position, FIG. 9B shows the mechanism in anintermediate position, and FIG. 9C shows the mechanism in a releasedposition.

FIG. 10 is a longitudinal section view showing an example of anophthalmic device.

FIGS. 11A-11C are cutaway views showing an example of a mechanismconfigured to inject a fluid. FIG. 11A shows a nut and a pump of themechanism with a linkage removed, FIG. 11B shows a linkage in an initialposition, and FIG. 11C shows the linkage in an actuated position.

FIG. 12A is a perspective view of an example of an ophthalmic device.

FIGS. 12B-12C are perspective and sectional views of internal componentsof the ophthalmic device of FIG. 12A.

FIGS. 12D-12F are various portion views of the internal components ofthe ophthalmic device of FIG. 12A, illustrating component action duringactuation.

FIG. 13A is a longitudinal section view showing an example of anophthalmic device.

FIGS. 13B-13C are perspective and sectional views of internal componentsof the ophthalmic device of FIG. 13A.

FIGS. 13D-13G are sectional portion views of internal components of theophthalmic device of FIG. 13A, illustrating component action duringactuation.

FIG. 14A is a perspective view of an example of an ophthalmic device andpriming syringe assembly.

FIGS. 14B-14C are portion views of internal components of FIG. 14A,illustrating component action during priming.

FIGS. 15A-15B are cutaway views showing an example of an ophthalmicprocedure that can be performed with an ophthalmic device. FIG. 15Ashows the ophthalmic device entering an anterior chamber and FIG. 15Bshows the ophthalmic device injecting a fluid into a Schlemm's canal.

DETAILED DESCRIPTION

The following detailed description is exemplary and explanatory only andis not restrictive of the features, as claimed. As used herein, theterms “comprises,” “comprising,” or other variations thereof, areintended to cover a non-exclusive inclusion such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements, but may include other elements not expressly listedor inherent to such a process, method, article, or apparatus.Additionally, the term “exemplary” is used herein in the sense of“example,” rather than “ideal.” As used herein, the terms “about,”“substantially,” and “approximately,” indicate a range of values within+/−5% of a stated value. The term “distal” refers to a portion farthestaway from a user when introducing a device into a subject. By contrast,the term “proximal” refers to a portion closest to the user when placingthe device into the subject.

Embodiments discussed below relate to a medical device, such as anophthalmic device configured for use in the treatment of glaucoma orother eye conditions, and related methods of use. According to someembodiments, the ophthalmic device can have a distal end including acannula. The cannula can include an inner lumen and one or more outfloworifices configured for delivery of viscoelastic fluid or othersubstance into a target site of a patient, such as a Schlemm's canal.

According to some embodiments, a tip of the cannula can include a collardisposed around an outer surface of the cannula. The collar can beconfigured to interact with intraocular tissue in an aqueous outflowpathway of a patient's eye to facilitate positioning of the cannula orfacilitate fluid transfer with respect to the eye. For example, thecollar can include a radially protruding lip that is fixed or movable toa position proximal to the orifices to provide a structure thatfacilitates positioning of the orifices of the cannula within or nearSchlemm's canal.

According to some embodiments, the collar can be implemented as part ofa retractable sleeve. The sleeve can be disposed around the cannula andconfigured to retract relative to the cannula to pull patient tissue viaa suction effect. For example, manipulation of a button or otheractuator component disposed on a handle of the device can be configuredto retract the sleeve to pull a trabecular meshwork over and around thecannula to penetrate the meshwork with the cannula and open up the canalto facilitate fluid delivery therein.

According to some embodiments, a mechanism can be configured to retractthe sleeve or otherwise move a component of the ophthalmic device with arelatively quick and sharp snapping motion. Such a motion can, forexample, facilitate suction of the patient's tissue and penetrationthereof by the cannula. Additionally or alternatively, the mechanism canoperate a pump to inject the fluid or substance through the cannula inconcert with the retraction of the sleeve.

These and other embodiments are discussed below in relation toparticular examples illustrated in FIGS. 1-9B. However, variousmodifications and alternative applications will be appreciated by thoseskilled in the art. Thus, the detailed description provided with respectto these figures as well as the description provided above should not beconstrued as limiting but rather serves to explain various conceptsassociated with this disclosure.

FIG. 1 shows an example of a medical device, and more particularly,shows an example of an ophthalmic device 10. In the example shown, theophthalmic device 10 is configured as a medical instrument or minimallyinvasive surgical instrument configured to interact with ocular tissueto facilitate injection of a substance into a Schlemm's canal or otherintraocular site of an eye of a patient. However, while examples hereinare described with reference to ophthalmic instruments and procedures,it will be appreciated that teachings of the ophthalmic device 10 can bereadily applied to or adapted for any of a variety of other medical andnon-medical applications. These can include, for example, other medicalprocedures involving interactions with patient tissue other than in thepatient's eye, and other non-medical applications involving fluidinjection or transfer.

Referring to FIG. 1, the ophthalmic device 10 can include a handle 12coupled to an ocular component 21. The ocular component 21 is generallyconfigured for interacting with ocular tissue and/or insertion into anintraocular cavity, such as the anterior chamber of an eye of a patient.The ocular component 21 can be configured to facilitate fluid delivery,tissue manipulation, and/or other interactions with the eye of thepatient.

As shown in the example of FIG. 1, the ocular component 21 can includean elongated tubular member protruding from a distal end of the handle12 and defining a central longitudinal axis C. The ocular component 21can have a working length L and a diameter that permits insertion intothe anterior chamber through a corneal incision or other incision on aneye of a patient. The working length L described herein can be definedas the exposed length or distance of the ocular component 21 protrudingfrom the handle 12, extending from the distal end of the handle 12 tothe distal end of the ocular component 21. The working length L can be,for example, in the range of between about 16 millimeters (mm) and 40mm, or more particularly about 18 mm, although it contemplated thatother dimensions outside of these examples may be suitable in variousimplementations. The diameter may vary across the working length L or beconstant throughout the working length L and can be, for example, in therange of about 100 micrometers (μm) to 1000 μm, or more particularlyabout 700 μm, although it is contemplated that other dimensions outsideof these example may be suitable in various implementations. As shown inthe example of FIG. 1, the ocular component 21 can be implemented with astraight geometry (defining a straight central axis C), or the ocularcomponent 21 can be implemented with a curved and/or bent geometry.

With continued reference to FIG. 1, the handle 12 can be implemented asa main body of the ophthalmic device 10 and can be configured to bemanipulated by the hand of a user or other operator. For example asshown in FIG. 1, the handle 12 can be implemented as an elongatedtubular member having a distal end and a proximal end opposite to thedistal end. This can, for example, facilitate gripping or manipulationof the handle 12 using a pencil-grip by a surgeon, although it iscontemplated that handle 12 can be implemented with other shapes andconfigurations, such as pistol-shaped arrangements and/or finger loops.An outer surface of the handle 12 can include finger grips 13 having acontoured shape and/or textured surface (e.g., knurled, ribbed, or othersurface textures) to facilitate grasping of the handle 12 by the user.Implementations are also contemplated in which the outer surface of thehandle 12 has a straight non-contoured shape and/or a smooth outersurface.

The handle 12 can include or be coupled to an actuator 38. The actuator38 can be coupled to one or more moving parts of the ophthalmic device10 to provide one or more operative functions that facilitateperformance of an ophthalmic procedure using the device. For example,the actuator 38 can be configured to move one or more parts of theocular component 21 independently of the handle 12 and/or move two ormore moving parts of the ocular component 21 independently of eachother. Additionally or alternatively, the actuator 38 can be configuredto actuate a pump, plunger, and/or squeeze mechanism for fluid transferthrough the ocular component 21. The actuator 38 can, for example, beconfigured to move the part(s) directly or via an internal mechanismdisposed in the handle 12.

In the example shown in FIG. 1, the actuator 38 is implemented as orotherwise includes a mechanical push button disposed on the handle 12and movable between an un-pressed and pressed position. The push buttonis shown disposed on a lateral side of the handle 12 which can, forexample, facilitate actuation by a surgeon or other user using theirthumb and/or index finger when the handle 12 is grasped in the hand ofthe user during a procedure. Additionally or alternatively,implementations are contemplated in which the push button is disposed inother locations, such as a proximal end of the handle, for example.Implementations are also contemplated in which, instead of or inaddition to the push button, the actuator 38 includes a slider, rollerwheel, squeeze bulb, and/or any other suitable mechanism that can bemanipulated by a user or other operator to actuate a moving part of theophthalmic device 10.

FIGS. 2A and 2B are enlarged views showing an example of an ocularcomponent 21 that can be included in the ophthalmic device 10. FIGS. 2Aand 2B show a distal portion 27 of the ocular component 21 as indicatedin FIG. 1.

In the example shown in FIGS. 2A and 2B, the ocular component 21includes a cannula 14 and a sleeve 260 (also sometimes referred toherein as a “sheath”). The sleeve 260 is disposed around the cannula 14and the cannula 14 is disposed within the sleeve 260. The cannula 14 andthe sleeve 260 can, for example, each be implemented as substantiallytubular components in which the cannula 14 is disposed coaxially withthe sleeve 260 and both the cannula 14 and the sleeve 260 are disposedabout the central axis C. The cannula 14 and/or sleeve 260 can, forexample, each have a working length equivalent to the working length Lof the ocular component 21.

The cannula 14 and the sleeve 260 can be configured for relativemovement with respect to each other. For example as shown in FIGS. 2Aand 2B, the cannula 14 and the sleeve 260 can be moveable with respectto each other between a first configuration (shown in FIG. 2A) in whichthe distal end of the cannula 14 is substantially covered or encased bythe sleeve 260, and a second configuration (shown in FIG. 2B) in whichthe distal end of the cannula 14 protrudes distally from the distal endof the sleeve 260. The relative movement can be accomplished by, forexample, retraction of the sleeve 260 in a proximal directionindependently of the cannula 14 and the handle 12, and/or by deploymentof the cannula 14 in a distal direction independently of the sleeve 260and the handle 12. The actuator 38 can be operatively coupled to thecannula 14 and/or sleeve 260 to move the cannula 14 and/or sleeve 260with respect to a fixed component of the handle 12.

The cannula 14 can be configured to transfer a fluid or other substance.For example, the cannula 14 can be configured for injection of aviscoelastic fluid, such as sodium hyaluronate or chondroitin sulfate.Viscoelastic fluid is a highly pliable, gel-like material which helpsprovide enough space for adequate drainage and eye pressure relief byexpanding tissue structures away from one another, to re-open or expanda flow path of aqueous humor. Viscoelastic fluid also may clear anobstructed view by expanding bleeding structures away from one anotherto improve visualization. It is also contemplated that the cannula 14can be utilized to deliver stem cells, medicaments, gases (e.g., SF6 orC3F8), and/or dyes (e.g., trypan blue dye). Injected stem cells, forexample, can initiate growth of healthy tissues within the eye (e.g., todevelop healthy trabecular meshwork to enhance drainage of aqueous humorthere through). Injected dye, for example, can flow through thetrabecular meshwork to enhance visualization of aqueous humor fluid flowto determine which areas, if any, of the trabecular meshwork remainblocked, collapsed, or otherwise impede flow of aqueous humor. Further,while examples are described with respect to the injection ofsubstances, it is contemplated that the cannula 14 can additionally oralternatively be utilized to withdraw substances, such as to withdrawtissue, blood, aqueous humor, or other substances out of a Schlemm'scanal or other part of an eye.

As shown in FIG. 2B, the cannula 14 can be implemented as a bluntmicrocannula having a rounded, unsharpened, or otherwise atraumatic tipat its distal end. While implementations are also contemplated in whichthe cannula 14 is implemented with a sharp needle or traumatic tip atits distal end, the blunt cannula can facilitate penetration of porouspatient tissue, such as a trabecular meshwork, while mitigating risk ofundesired trauma to surrounding tissue.

The cannula 14 can include one or more orifices 32 disposed on a distalportion of the cannula 14, e.g., disposed on or near the cannula distalend. The one or more orifices 32 can provide one or more fluid transferports configured to transfer a fluid or other substance. For example,the one or more orifices 32 can be configured to provide outflow portsfor delivery of a viscoelastic substance to a Schlemm's canal of an eyeof a patient. As shown in the example of FIG. 2B, the one or moreorifices 32 can be disposed on a lateral side of the cannula 14 whichcan provide one or more fluidic channels through a sidewall of thecannula 14 in a direction transverse to the central axis C.Alternatively, other implementations are contemplated in which theorifices are disposed along the central axis C and/or in any other oneor more suitable positions to transfer fluid to and/or from an intendedtarget site. The orifices can each have a diameter of between 30 μm to70 μm, or such as about 50 μm or about 60 μm, although it iscontemplated that other orifice diameters outside of these ranges may besuitably used in various implementations. The cannula 14 may include oneor more grooves 34 disposed on a distal portion of the cannula 14.

As shown for example in FIGS. 2A and 2B, relative movement between thesleeve 260 and the cannula 14 can be configured to selectively cover anduncover one or more of the orifices 32 with the sleeve 260. For example,when in the first configuration shown in FIG. 2A, the distal end of thesleeve 260 can be disposed at a first axial position distal to theorifice(s) 32 so as to cover or surround the orifice(s) 32, and when inthe second configuration shown in FIG. 2B, the distal end of the sleeve260 can be disposed at a second axial position proximal to theorifice(s) 32 so as to expose the orifice(s) 32 outside of the distalend of the sleeve 260.

The ophthalmic device 10 can further include a collar 299 disposed abouta circumference of a tip of the cannula 14 at or near the cannula distalend. For example as shown in FIGS. 2A and 2B, the collar 299 can be anintegral part of the sleeve 260 or otherwise fixedly coupled to thesleeve 260 at the sleeve distal end, in which case collar 299 can movetogether with the sleeve 260 so that the collar 299 and the cannula 14are movable relative to each other. The collar 299 can provide astructure disposed about a circumference of the cannula 14 (e.g., on oraround an outer diameter of the cannula 14) that is configured tointeract with patient tissue so as to facilitate placement of thecannula 14. For example, a face 451 of the collar 299 at the distal endof the collar can be configured to manipulate a trabecular meshworkand/or provide a guiding constraint that abuts the trabecular meshworkand/or other tissue neighboring Schlemm's canal. This guiding constraintmay, for example, facilitate placement of the orifice(s) 32 to a desiredpenetration depth within the canal.

In the example shown in FIGS. 2A and 2B, the collar 299 is included aspart of a distal portion of the sleeve 260. When the sleeve 260 and thecannula 14 are in the second configuration shown in FIG. 2B, the face451 of the collar 299 provides a lip that protrudes radially outwardaway from an outer diameter of the cannula 14. The lip can abut atrabecular meshwork or other tissue neighboring Schlemm's canal so thatthe penetration depth of the cannula 14 is constrained or guided by apredetermined distance between the distal end of the cannula 14 and thelip (or the face 451 or distal end of the collar 299) when the device isin the second configuration.

FIGS. 3A and 3B are longitudinal section views showing a distal portion27 of an example of an ocular component 21 interacting with oculartissue. FIG. 3A shows the sleeve 260 in a distal position, and FIG. 3Bshows the sleeve 260 in a retracted position in which the sleeve 260 isretracted in a proximal direction 99 as shown by the arrow.

As shown in FIGS. 3A and 3B, the collar 299 at the distal end of thesleeve 260 can be configured to contact patient tissue, and the sleeve260 can be configured to retract proximally so as to pull patient tissueover the cannula 14. For example, the sleeve 260 can be configured toretract in a proximal direction 99 using a snapping motion (i.e., asharp and quick motion) so as to create a suction microenvironment overa trabecular meshwork 86 of an eye of a patient when the sleeve 260and/or collar 299 is pressed against the trabecular meshwork 86. Thesleeve 260 via its snapping motion can pull and expand the trabecularmeshwork 86 proximally, which may also serve to expand a Schlemm's canal80 as the trabecular meshwork 86 vaults away from the anterior wall ofthe canal. Concurrently with the pulling of the trabecular meshwork 86,the distal end of the cannula 14 may be left in place so that thetrabecular meshwork 86 passes over the cannula 14 and the cannula 14pierces or penetrates the trabecular meshwork 86, leaving the orifice(s)32 in place inside of the Schlemm's canal 80. When the trabecularmeshwork 86 is pulled and the orifice(s) 32 are positioned in theSchlemm's canal 80, the ophthalmic device 10 may be configured todeliver a substance into the Schlemm's canal 80 via a lumen 95 in thecannula 14 that is fluidly coupled to the orifice(s) 32. The proximalretraction of the sleeve 260 may beneficially serve to expand theSchlemm's canal 80 and/or otherwise facilitate fluid delivery and/ortreatment via penetration by the cannula 14. It is also contemplatedthat the substance may be injected in some implementations by deployingthe cannula 14 distally while the sleeve 260 remains in place, by movingthe cannula 14 proximally or distally together with the sleeve 260,and/or by other techniques.

FIGS. 4A and 4B are longitudinal side views showing examples of thesleeve 260 interacting with ocular tissue. FIG. 4A shows a first exampleof sizing that can be implemented at the distal end of the sleeve 260,and FIG. 4B shows a second example of sizing that can be implemented inthe distal end of the sleeve 260. FIGS. 4A and 4B show trabecularmeshwork 86 and Schlemm's canal 80 as well as other neighboring eyeanatomy, such as a scleral spur 71, ciliary muscle 69, and Schwalbe'sline 67.

As shown in both FIGS. 4A and 4B, a size of a distal end of the sleeve260 (or a size of the face 451 or distal end of the collar 299) can besufficiently small so as to permit the distal end to be inserted in theiridocorneal angle using an ab interno approach (approach from withinthe anterior chamber) to abut against and contact the trabecularmeshwork 86. In the example shown in FIG. 4A, the size of the distal endof the sleeve 260 is made sufficiently large so that the distal end isconfigured to abut against both the trabecular meshwork 86 andneighboring anatomy that is more rigid than the trabecular meshwork 86,such as scleral spur 71, so as to substantially prevent collapse of thetrabecular meshwork 86 within Schlemm's canal 80 when the distal end isadvanced against the trabecular meshwork 86. In the example shown inFIG. 4B, the size of the distal end of the sleeve 260 is madesufficiently small so that the distal end is configured to collapse thetrabecular meshwork 86 within Schlemm's canal 80 when the distal end ispressed against the trabecular meshwork 86, e.g., in a region betweenscleral spur 71 and Schwalbe's line 67. In either example, upon abuttingagainst the trabecular meshwork 86, the distal end may be configured tocreate a full or partial seal against the trabecular meshwork 86 and/orother ocular tissue together with surrounding fluids such as aqueoushumor and/or viscoelastic (e.g., ophthalmic viscoelastic device (OVD)).The ophthalmic device 10 can then be configured to retract the sleeve260 to pull on the trabecular meshwork 86 as described above withrespect to FIGS. 3A and 3B. Further, it is contemplated that the distalend can have an oblong cross sectional shape with a long side sized likethat shown in FIG. 4A and a short side sized like that shown in FIG. 4B.The long side can be configured to contact the rigid anatomy uponadvancement against the trabecular meshwork 86 when the long side isoriented transverse to the direction in which the trabecular meshwork 86extends around the lens of the eye, and the short side can be configuredto collapse the trabecular meshwork 86 in the Schlemm's canal 80 whenthe long side is aligned with the direction in which the trabecularmeshwork 86 extends.

FIGS. 5A-5C are various views of a distal portion of an example ofsleeve 260 including collar 299. FIG. 5A is a perspective view of thesleeve 260, FIG. 5B is a top view of the sleeve 260 as implemented inFIG. 5A, and FIG. 5C is a side view of the sleeve 260 as implemented inFIG. 5A.

As shown for example in FIGS. 5A-5C, the collar 299 (e.g., the face 451)and the distal end of the sleeve 260 can have an oblong cross-sectionalshape (e.g., an oval, an ellipse, a rounded corner rectangle, or otheroblong shape). The oblong shape has a pair of opposing long sides 93 anda pair of opposing short sides 96. The long sides 93 define a long axis85 of the oblong cross-section and the oblong cross-section has a longouter diameter D_(LONG) along the long axis 85. The short sides 96define a short axis 89 of the oblong cross-section and the oblongcross-section has a short outer diameter D_(SHORT) along the short axis89 smaller than the long diameter D_(LONG). As shown for example in FIG.5B, the collar 299 and the distal end of the sleeve 260 can include apair of diverging outer surfaces 79 on opposing sides of the sleeve 260that diverge (or flare radially outward) towards opposing short sides ofthe distal end of the sleeve 260. As shown for example in FIG. 5C, thecollar 299 and the distal end of the sleeve 260 can also include a pairof converging outer surfaces 75 on opposing sides of the sleeve 260 thatconverge (or taper radially inward) towards opposing long sides of thedistal end of the sleeve 260. As a result, the long outer diameterD_(LONG) can be greater than the outer diameter D_(PROX) of a proximalportion of the sleeve 260, while the short outer diameter D_(SHORT) canbe smaller than the outer diameter D_(PROX) of a proximal portion. Thedistal end of the sleeve 260 can be sized to fit within an iridocornealangle (angle formed between the iris and the cornea) to permit thedistal tip to contact or press against the trabecular meshwork and/orscleral spur of an eye, and the above described orientation with flaredconfiguration along the long axis 85 can be useful to, for example,indicate a preferential orientation of the sleeve tip for the surgeon toproperly place the tip to avoid over compressing the trabecular meshworkand/or Schlemm's canal.

The collar 299 and/or the sleeve 260 can further be configured as alight guide to enhance visualization when placed in the eye. Forexample, a light source such as one or more light emitting diode (LEDs)can be disposed in the handle 12 or otherwise positioned on theophthalmic device 10 proximal to the distal end of the sleeve 260. Thelight source can be configured to couple visible light into thesidewalls of the sleeve 260 so that the light propagates through thesidewalls of the sleeve 260 via total internal reflection (TIR) and outof the distal end or distal portion of the sleeve 260 (e.g., out theface 451). Additionally or alternatively, the sleeve 260 can be madetransparent or include one or more transparent windows to facilitatevisualization of the sleeve 260 and/or the cannula 14, although it iscontemplated that the sleeve 260 can be made wholly opaque to visiblelight in other implementations.

FIGS. 6A-6C are various views of a distal portion of an example ofsleeve 260 including collar 299. FIG. 6A is a perspective view of thesleeve 260, FIG. 6B is a top view of the sleeve 260 as implemented inFIG. 6A, and FIG. 6C is a side view of the sleeve 260 as implemented inFIG. 6A. As shown for example in FIGS. 6A-6C, an outer surface of thecollar 299 and outer surface of a distal portion of the sleeve 260 canfurther include grooves 101. The grooves 101 may enhance a suctioneffect when the sleeve 260 and collar 299 are retracted proximally byincreasing a surface area of the outer surface of that contacts fluids,such as OVD or other surrounding fluids that can be disposed in theanterior chamber of the eye. The grooves 101 are shown in FIGS. 6A-6C asa plurality of circumferential grooves that extend around an outercircumference of the sleeve 260 and are disposed in a converging regionof the collar 299 at a distal portion of the sleeve 260, but it iscontemplated that the grooves 101 can be implemented as other types ofsurface area enhancing textures and/or positioned in other locationsalong an axial length of the sleeve.

It is also contemplated, for example as shown in FIGS. 7A-7C, that thecollar 299 can be fixedly coupled to the cannula 14. FIG. 7A is aperspective view of cannula 14, FIG. 7B is a top view of the cannula 14as implemented in FIG. 7A, and FIG. 7C is a side view of cannula 14 asimplemented in FIG. 7A.

In this example, an independently movable sleeve may be omitted from theophthalmic device 10. For example, the collar 299 can be integrallyformed as part of an outer portion of the cannula 14, or the collar 299can be welded or otherwise fixedly attached to the cannula 14 so thatthe collar 299 moves together with the cannula 14. The fixedly coupledcollar 299 can have an oblong cross-sectional shape or any of the otherfeatures described above with respect to the collar 299 when implementedon the sleeve. As shown for example in FIGS. 7A and 7B, a lip can beprovided by a face of the collar 299 and protrude radially outward froma distal portion of cannula 14. The lip can thus provide a structure forinteracting with tissue as described above. As shown for example in FIG.7B, a radial length L_(R) of lip can be approximately equal to an axiallength L_(A) of the protruding portion of the cannula 14, although it iscontemplated that other dimensions may be suitably used. In thisexample, the lip length L_(R) is defined by the distance between theradially outermost surface of the lip and the radially outermost surfaceof the axially protruding section of the cannula 14 from which the lipcan extend. The cannula tip length L_(A) is defined by the axial lengthfrom the lip (or from the face 451 or distal end of the collar 299) tothe distal end of the cannula 14. The cannula 14 may have an increaseddiameter in a portion proximal to the collar 299 than in a portiondistal to the collar 299. This may beneficially enhance rigidity orstructural integrity of the cannula 14 across its working length, whilepermitting the distal end of the cannula 14 to be made sufficientlysmall in diameter for insertion into Schlemm's canal or another suitabletarget site of the patient. It is also contemplated that any of thesedimensions or geometric features described with respect to the fixedcollar shown in FIGS. 7A-7C can be suitably used in implementationswhere the collar is part of the sleeve 260 or otherwise movable withrespect to the cannula 14 and disposed in a second configuration likethat shown in FIG. 2B.

FIG. 8 is a longitudinal section view showing a distal portion of anexample of ocular component 21 that can be included in ophthalmic device10. In the example shown in FIG. 8, the cannula 14 is shown in aprotruding position relative to the sleeve 260 (e.g., in the secondconfiguration like that shown in FIG. 2B). The cannula 14 is composed ofa plurality of segments including a tip segment 151 and a proximal shaftsegment 153. The tip segment 151 can be attached to the proximal shaftsegment 153 by, for example, laser welding or any other suitablefastening mechanism. The tip segment 151 has an inner diameter D_(SMALL)and the proximal shaft 153 has an inner diameter D_(LARGE) that isgreater than the inner diameter D_(SMALL) of the tip segment 151.Accordingly, the lumen 95 extending through the cannula 14 is segmentedto have a proximal portion 163 that is larger in diameter than thedistal portion 161. This can, for example, reduce back pressure in thedevice, although implementations are also contemplated in which thecannula 14 is composed of a single piece or integral construction,and/or in which the lumen 96 has a substantially constant diameterthrough the cannula 14.

FIG. 8 also shows the collar 299 configured as shown in the example ofFIGS. 5A-5C, in which the collar 299 is implemented at the distal end ofthe sleeve 260 so that a distal tip of the sleeve 260 has an oblongcross section with flared diverging outer surfaces 79 on opposing sidesof the sleeve 260. As shown in the example of FIG. 8, the one or moreorifices 32 can include a pair of orifices on opposing sides of thecannula 14 (e.g., oriented approximately 180 degrees apart from oneanother about the circumference of the cannula 14). The pair of opposingorifices can be aligned along the long axis 85 of the distal tip(aligned along the long axis of the oblong cross section of the collar299) so that the orifices 32 face the short sides 96 of the sleevedistal end and face the diverging outer surfaces 79. This can, forexample, allow the flared or diverging surfaces to serve as an indicatorfor bringing the orifices of the cannula 14 into the Schlemm's canalwith an orientation that points the injected fluid towards the directionof extent of the canal. Although shown in an implementation in which thecollar 299 is fixedly coupled to a movable sleeve 260, it is alsocontemplated that this orientation of the orifices 32 can be applied toimplementations in which the collar 299 is fixed to the cannula 14 likein the example of FIGS. 7A-7C.

FIGS. 9A-9C are side views showing an example of an internal mechanism301 that can be included in the ophthalmic device 10 and utilized toretract sleeve 260. The internal mechanism 301 can, for example, bedisposed in an internal volume of the handle 12 and coupled to theactuator 38.

FIG. 9A shows the internal mechanism 301 in an initial loaded state,FIG. 9B shows the internal mechanism 301 in an intermediate state, andFIG. 9C shows the internal mechanism 301 in a released state during orafter retraction of the sleeve 260. The internal mechanism 301 shown inFIGS. 9A-9C utilizes a cam and follower system to retract sleeve 260 ina proximal direction 99 relative to the cannula 14 and relative to thehandle 12 (sleeve 260, cannula 14, and handle 12 not visible in FIGS.9A-9C). More particularly, the internal mechanism 301 includes a cam 311coupled to a catch 321 and a spring-loaded follower 331. The follower331 can be fixedly coupled to the sleeve 260 so that the sleeve 260moves together with the follower 331. The catch 321 is configured tohold the follower 331 in a distal position, and the cam 311 isconfigured to move the catch 321 to release the follower 331 in aproximal direction 99. The cam 311 can be coupled to a push button (suchas that shown in FIG. 1) to permit the cam 311 to be moved or actuatedby the push button.

In FIG. 9A, the internal mechanism 301 is shown in an initial state. Inthis state, the follower 331 (and the sleeve 260) are in a distalposition. The catch 321 is in a first position in which it holds thefollower in the distal position by, for example, abutting a proximalsurface of the follower 331 to prevent or restrict proximal movement ofthe follower 331. While the catch is in the first position and thefollower is in the distal position, a spring 335 applies a spring forceto the follower 331 in a proximal direction 99. The spring 335 is shownin FIGS. 9A-9C as an axial compression spring, but it will beappreciated that a variety of other springs can be suitably used. Thepush button (not visible in FIG. 9A) can be coupled to the cam 311 andis in an un-pressed position (e.g., an upper position) when the internalmechanism 301 is in the initial state. Application of a user force tothe push button can urge rotational movement of the cam 311 in a firstcam rotational direction 355 about cam pivot point 343. As the cam 311rotates in the first cam rotational direction 355, the cam 311 rotatesagainst the catch 321 to urge movement of the catch 321, for example, toflex in a direction 373 away from the first position of the catch andtowards a second position of the catch.

In FIG. 9B, the internal mechanism 301 is shown in an intermediate stateas the above forces are being applied. As shown in FIG. 9B, a gap 381can be formed between the cam 311 and the follower 331 upon rotation ofthe cam 311 in the first rotational direction 355. For example, as thecam 311 rotates against the catch 321, the catch 321 can continue tohold the follower 331 in a distal position while the cam 311 rotatesaway from the follower 331 in the first cam rotational direction 355.The gap 381 can provide a clearance for the follower 331, together withthe sleeve 260, to freely move so that potential energy held in thespring 335 can cause a quick and sharp snapping motion upon release ofthe follower 331 by the catch 321.

In FIG. 9C, the internal mechanism 301 is shown in a retracted orretracting state in which the follower 331 is released by the catch 321.As shown in FIG. 9C, upon sufficient rotation of the cam 311 against thecatch 321, the cam 311 can release the follower 331 by, for example,moving the catch 321 to a second position in which the catch 321releases the follower 331 by, for example, removing a restriction withwhich a distal surface of the catch 321 abuts against a proximal surfaceof the follower 331. Upon release of the follower, potential energystored in the spring 335 is released to urge proximal motion of thefollower 331 (and thus the sleeve 260) in the proximal direction 99. Thefollower 331 can move freely through the gap 381 to a proximal positionuntil it is stopped by a restriction. For example, the proximal motionof the follower 331 can terminate upon the follower 331 abutting the cam311, upon abutting a stop included in a housing of the handle 12 (notvisible in FIG. 9C), and/or upon abutting a stop included on the catch321. The surface that provides a stop for the follower 331 can, forexample, be relatively rigid or can include a cushion or energyabsorbing member so as to soften an impact and prevent shocks fromtransmitting through the device and to a surgeon's hand.

In FIG. 9C, the catch 321 is shown in a second position (releasedposition). The catch 321 can be biased to the first position (abuttingposition shown in FIG. 9A) so as to permit the internal mechanism 301 tobe reset to the initial state upon, for example, release of the pushbutton by a user. For example, after retraction of the follower 331,upon release of the push button, the bias of the catch 321 towards thefirst position can cause the catch 321 to move upwards to urgerotational movement of the cam 311 in a second cam rotational directionopposite to the first cam rotational direction 355. As the catch 321urges the rotation of the cam 311 in the opposite direction, the cam 311urges the follower 331 (or the catch 321 urges the follower via the cam311) in a distal direction so as to move the follower 331 from thefollower proximal position to the follower distal position to reload thespring 335. As the catch 321 urges the rotation of the cam 311 and movesthe follower 331 in this manner, the catch 321 can also return to thefirst position where it abuts the follower 331 to hold the follower 331in the distal position. The internal mechanism 301 can then be operatedagain in a similar fashion for one or more repeated sleeve retractions.

While the mechanism has been described with respect to implementationsin which the internal mechanism 301 is utilized to retract sleeve 260(e.g., to pull a trabecular meshwork via a snapping motion like thatdescribed above with respect to the example of FIGS. 3A-3B), it will beappreciated that the mechanism may be suitably used for other modes ofoperation. For example, the snapping motion created by the mechanism canbe utilized to snap the cannula 14 and/or sleeve 26 proximally and/ordistally to create a vibration (e.g., upon impact of the follower 331against a stop) that facilitates penetration of the trabecular meshworkwithout a need for a suction effect. Thus, the follower 331 can befixedly coupled to the cannula 14 or any other suitable component forwhich motion is desired. It will also be appreciated that if themechanism is employed for distal motion of the sleeve 260, cannula 14,or any other component, the various parts and operation of the mechanismcan be reversed. It is further contemplated that other mechanisms, suchas magnetic actuators or other types of spring loaded actuators can beemployed for retraction of the sleeve 260.

FIG. 10 is a longitudinal section view showing an example of ophthalmicdevice 10. FIG. 10 shows an example of a structure for handle 12 and afluid delivery mechanism that can be included in the handle 12 tofacilitate delivery of a substance through the ocular component 21.

As shown in FIG. 10, the handle 12 can include a housing 513 thatencloses and defines an internal volume 517. A lumen 525 (sometimesreferred to herein as “handle lumen”) can be disposed in the handle 12and be fluidly coupled to the lumen 95 (sometimes referred to herein as“cannula lumen”) protruding from the distal end of the handle 12. Thehandle lumen 525 can, for example, extend through the internal volume517 and be configured to deliver fluid to the cannula lumen 95 from afluid source, such as a fluid reservoir disposed within the internalvolume or coupled to the handle externally.

As shown for example in FIG. 10, the handle 12 can include an inlet port531 configured to couple to the fluid source and to receive an inletfluid. The inlet port 531 can, for example, include a luer lockconnector or any other suitable connector configured to connect to aviscoelastic syringe or any other suitable fluid reservoir. The inletport 531 is shown in FIG. 10 disposed on a proximal end of the handle 12so as to provide an inlet channel extending through an opening in aproximal end of the handle housing 513. Additionally or alternatively,the inlet port 531 can be disposed on another location on the handle 12,such as on a lateral sidewall of the handle 12. In the example shown inFIG. 10, the handle 12 holds a reservoir 599 that can be filled with aninitial volume of fluid or other substance via the inlet port 531.

The handle 12 shown in FIG. 10 further includes a pump 611 which can beconfigured to move fluid through the handle lumen 525 and/or through thecannula lumen 95. For example as shown in FIG. 10, the pump 611 caninclude or be coupled to a piston 598 disposed within the internalvolume 517 of the handle 12 and configured to translate in an axialdirection proximally and/or distally. The piston pump can be configuredto move in the distal direction from a proximal pump position to adistal pump position to draw fluid from the inlet port 531 and/or tourge or push fluid out through the distal end of the cannula lumen 95and out through the orifice(s) 32. Thus, the pump 611 can be configuredfor positive and/or negative displacement of fluid. The piston 598 canalso, for example, be reciprocal in the housing and configured to movein a proximal direction, from the distal pump position to the proximalpump position, so as to reset for delivering a subsequent dosage offluid. Alternatively, the piston 598 can be configured to moveincrementally in a distal direction in which each increment of distalmotion corresponds to a dosage of fluid or other substance.

The pump 611 can include or be coupled to a valve 639 which can bedisposed in the fluidic pathway of the handle lumen 525 and be fixedlycoupled to the pump 611 so as to move together with the pump 611. Thevalve 639 can, for example, be implemented as or otherwise include aone-way valve (or “check valve”) that permits fluid motion there throughin a distal direction and restricts fluid motion there through in aproximal direction so as to create suction from the inlet port 531 andto force fluid out of the orifice(s) upon distal motion of the valve 639together with the handle 12. Additionally or alternatively, it will beappreciated that various other types of pumps and/or fluid transfermechanisms can be configured to move the fluid through the ophthalmicdevice 10.

The pump 611 can further be coupled to actuator 38 so as to permitactuation of the pump for delivery of a dosage or amount of fluid uponactuation of the actuator 38. The pump 611 can, for example, be coupledto the same actuator that moves the sleeve 260 or other part of theocular component 21, or the pump 611 can be coupled to a separateactuator from that used to move the ocular component 21. In the exampleshown in FIG. 10, the actuator 38 includes a push button coupled to thepump 611 and configured trigger delivery of a discrete dosage of fluidupon user depression of the push button.

FIGS. 11A-11C are cutaway views of the handle 12 of ophthalmic device 10in which the actuator 38 is configured to actuate motion of the distalocular component as well as the pump 611 in concert with each other.FIG. 11A is a cutaway view showing the internal mechanism with a linkageand cam removed for clarity. FIGS. 11B and 11C are cutaway views showingthe internal mechanism with linkage 723 and cam 311 illustrated in aninitial position before button press, and in an actuated position afterbutton press, respectively.

The mechanism shown in FIGS. 11A-11C can be used so that each buttonpress of the actuator 38 is a trigger that causes both retraction of thesleeve 260 (e.g., to pull trabecular meshwork 86 over the cannula 14 asshown in FIGS. 3A-3B) and delivery of a dosage of fluid through thecannula 14 while the sleeve 260 is retracted (e.g., while the trabecularmeshwork 86 is pulled over the cannula 14 and the orifice(s) 32 arepositioned within the Schlemm's canal 80 as shown in FIGS. 3A-3B). Asshown for example in FIG. 11A, the mechanism can include a nut 779coupled to a threaded portion 781 which is included in or fixedlycoupled to the pump 611. The nut 779 can be mated with the threadedportion 781 so that rotation of the nut 779 drives axial motion of thepump 611 (e.g., translation in a distal direction) so as to cause thepump 611 to move fluid through the handle 12.

As shown in FIGS. 11B and 11C, the actuator 38 can be implemented as apush button coupled to the nut 779 via a linkage 723. As shown in FIGS.11B and 11C, the same push button that drives the nut 779 can also becoupled to cam 311, directly or via the linkage 723. Upon a user forcedepressing the button from the un-pressed position shown in FIG. 11B tothe pressed position shown in FIG. 11C, the push button can driverotation of the cam in the first rotational direction 355 (e.g., toretract sleeve 260) and drive rotation of the nut 779 via the linkage723, so as to move the piston 598 incrementally forward distally to movefluid through the handle 12 via positive displacement. Concurrently, therotation of the cam 311 causes retraction of the sleeve 260 so thesubstance is delivered by the pump 611 while the sleeve 260 is in aretracted proximal position.

FIGS. 12A-12F illustrate an ophthalmic device 110 in which an actuatoris configured to actuate motion of a distal ocular component as well asa pump in concert with each other. FIG. 12A shows a perspective view ofophthalmic device 110. FIGS. 12B and 12C show perspective and sectionalviews of internal components of the ophthalmic device 110. FIGS. 12D-12Fshow various views of portions of the internal components duringactuation of ophthalmic device 110.

Referring to FIG. 12A, ophthalmic device 110 has many of the samecomponents as ophthalmic device 10, which are numbered the same forconsistency. Ophthalmic device 110 can include a handle 112 coupled tothe ocular component 21. The handle 112 may be sized and shaped toprovide easy gripping by a healthcare provider (e.g., ophthalmicsurgeon) with minimum stress on the healthcare provider's hand. An outersurface of the handle 112 includes finger grips 113 having a contouredshape and a ribbed surface to facilitate grasping of the handle 112 bythe user. The actuator 38 is a mechanical push button disposed on thehandle 112 and movable between an un-pressed and pressed position. Thehandle 112 may include a viewing port 114 (e.g., a dispensing volumeindicator), or the handle 112 may be essentially opaque with no viewingport. The handle 112 can include an inlet port 831 configured to coupleto the fluid source and to receive an inlet fluid. The inlet port 831may include any of the configurations and/or features of inlet port 531.

The internal components shown in FIGS. 12B and 12C can be used so thateach button press of the actuator 38 is a trigger that causes bothretraction of the sleeve 260 (e.g., to pull trabecular meshwork 86 overthe cannula 14 as shown in FIGS. 3A-3B) and delivery of a dosage offluid through the cannula 14 while the sleeve 260 is retracted (e.g.,while the trabecular meshwork 86 is pulled over the cannula 14 and theorifice(s) 32 are positioned within the Schlemm's canal 80 as shown inFIGS. 3A-3B). As shown for example in FIGS. 12B and 12C, the internalcomponents can include a drive nut 879 coupled to a threaded portion881, which is included in or fixedly coupled to a plunger 811 (e.g.,pump). The drive nut 879 can be mated with the threaded portion 881 sothat rotation of the drive nut 879 drives axial motion of the plunger811 (e.g., translation in a distal direction) so as to cause the plunger811 to move fluid through the handle 112.

As shown in FIGS. 12B-12F, the actuator 38 can be implemented as a pushbutton coupled to the drive nut 879 via a linkage arm 823. The drive nut879 may have multiple teeth 875, each tooth 875 having a flat portion876 and a sloped portion 877. The linkage arm 823 may have an engagementportion 827 that is sized and shaped to grab onto the flat portion 876of a tooth 875. The same push button 38 that drives the drive nut 879can also be coupled to cam 311 via a protrusion 824. Upon a user force850 depressing the button 38 from the un-pressed position shown in FIG.12D, the button 38 may rotate about an actuator axle 39, causing theprotrusion 824 to push down on the cam 311 and the linkage arm 823 topull up on the tooth 875 of the drive nut 879 to which the linkage arm823 is engaged. Accordingly, the button 38 can drive rotation of the cam311 via the protrusion 824 in the first rotational direction 355 (e.g.,to retract sleeve 260) and drive rotation of the drive nut 879 in adrive rotational direction 855 (e.g., counterclockwise) via the linkagearm 823, so as to move a plunger tube 898 incrementally forward (e.g.,distally) a stroke length 870 to move fluid through the handle 112 viapositive displacement. The plunger tube 898 may have a plunger seal 899(e.g., a wavy seal) to prevent backflow of the substance. Concurrentlywith the drive nut 879 rotation, the rotation of the cam 311 causesretraction of the sleeve 260 so the substance is delivered by theplunger 811 while the sleeve 260 is in a retracted proximal position.

As shown in FIG. 12F, a side panel shim 890 may engage with the teeth875 of the drive nut 879 in a ratchet process. For example, as the drivenut 879 rotates in the drive rotational direction 855, an engagementportion 891 of the side panel shim 890 may ride up the sloped portion877 of a tooth 875 and then drop down along the trailing flat portion876 of the tooth 875, thus allowing the drive nut 879 to rotate in thedrive rotational direction 855 with little or no resistance. However,when the engagement portion 891 of the side panel shim 890 is engagedwith the flat portion 876 of a tooth 875, the side panel shim 890resists rotation of the drive nut 879 in the opposite rotationaldirection (e.g., clockwise).

FIGS. 13A-13G illustrate an ophthalmic device 210 in which an actuatoris configured to actuate motion of a distal ocular component as well asa pump in concert with each other. FIG. 13A shows a perspective view ofophthalmic device 210. FIGS. 13B and 13C show perspective and sectionalviews of internal components of the ophthalmic device 210. FIGS. 13D-13Gshow views of portions of the internal components during actuation ofophthalmic device 210.

Referring to FIG. 13A, ophthalmic device 210 has many of the samecomponents as ophthalmic device 10, which are numbered the same forconsistency. Ophthalmic device 210 can include a handle 212 coupled tothe ocular component 21. The handle 212 may be sized and shaped toprovide easy gripping by a healthcare provider (e.g., ophthalmicsurgeon) with minimum stress on the healthcare provider's hand. An outersurface of the handle 212 may include finger grips 213 having acontoured shape and a ribbed surface to facilitate grasping of thehandle 212 by the user. The actuator 38 is a mechanical push buttondisposed on the handle 212 and movable between an un-pressed and pressedposition. The handle 212 may include a viewing port (not shown), or thehandle 212 may be essentially opaque with no viewing port. The handle212 can include an inlet port 931 configured to couple to the fluidsource and to receive an inlet fluid. The inlet port 931 may include anyof the configurations and/or features of inlet port 531.

The internal components shown in FIGS. 13B and 13C can be used so thateach button press of the actuator 38 is a trigger that causes bothretraction of the sleeve 260 (e.g., to pull trabecular meshwork 86 overthe cannula 14 as shown in FIGS. 3A-3B) and delivery of a dosage offluid through the cannula 14 while the sleeve 260 is retracted (e.g.,while the trabecular meshwork 86 is pulled over the cannula 14 and theorifice(s) 32 are positioned within the Schlemm's canal 80 as shown inFIGS. 3A-3B). As shown for example in FIGS. 13B and 13C, the internalcomponents can include a drive gear 979 coupled to a rack portion 981,which is included in or fixedly coupled to a plunger 911 (e.g., pump).Drive gear teeth 977 can be engaged with rack portion teeth 983 so thatrotation of the drive gear 979 drives axial motion of the plunger 911(e.g., translation in a distal direction) so as to cause the plunger 911to move fluid through the handle 212.

As shown in FIGS. 13B-13G, the actuator 38 can be implemented as a pushbutton coupled to a trigger gear 969. Trigger gear teeth 967 can beengaged with actuator teeth 37 and the trigger gear 969 can be rotatedby pushing down on the actuator 38. The trigger gear 969 can be coupledto the drive gear 979 via a drive axle 923. The trigger gear 969 canalso be coupled to a sleeve follower 971 via a cam portion 31. Upon auser force 850 depressing the button 38 from the un-pressed positionshown in FIG. 13D, the button 38 may cause the cam portion 31 to rotatethe sleeve follower 971 so that a hill portion 972 of the sleevefollower 971 rotates to a valley portion 973 of the sleeve follower 971,causing the sleeve 260 to snap back (e.g., proximally) to retract thesleeve 260. Depressing the button 38 from the un-pressed position shownin FIG. 13D may also cause the trigger gear 969 to rotate the drive axle923, further causing the drive gear 979 to rotate. Accordingly, thebutton 38 can drive rotation of the drive gear 979 via the drive axle923 in a drive rotational direction 955 to drive movement of the rackportion 981, so as to move the plunger 911 incrementally forward (e.g.,distally) a stroke length 970 to move fluid through the handle 212 viapositive displacement. The plunger 911 may have a rear seal 999 (e.g.,O-ring seal). Concurrently with the drive gear 979 rotation, themovement of the cam portion 31 causes retraction of the sleeve 260. Thesubstance is delivered by the plunger 911 beginning with actuation ofthe actuator 38 and through retraction of the sleeve 260 in a proximalposition.

As shown in FIG. 13F, a one-way clutch 990 may provide for the drivegear teeth 977 of the drive gear 979 to engage the rack portion teeth983 of the rack portion 981 in a ratchet and/or index process. Forexample, after the drive gear 979 rotates in the drive rotationaldirection 955 to move the rack portion the stroke length 970, theone-way clutch 990 allows the trigger gear 969 to rotate in the oppositedirection without causing the drive gear 979 or drive axle 923 to rotatefurther in any direction, thus keeping the rack portion 981 in positionwhile the button 38 resets (e.g., when the button 38 moves back to theun-pressed position shown in FIG. 13D). Thus, the one-way clutch 990allows the drive gear 979 to rotate in the drive rotational direction955 only so that the drive gear 979, and also the rack portion 981, stayin the same position when the button 38 is reset. The button 38 can bemoved back to the un-pressed position when the user force 850 is removed(e.g., the user stops pressing down on the button 38) via a spring 984(e.g., torsion spring), where a biasing force 960 pushes the button 38back to the initial un-pressed or reset position. Once the button 38 isreset, the button 38 may be pressed again to start the process overagain.

Each trigger of the button 38 may cause the button 38 to swing adistance (e.g., 20 degrees) and may cause the rack portion 981 to moveforward a set number of rack portion teeth 983 (e.g., two teeth). Thus,the movement of the rack portion 981 may be a stroke length 970 of onetenth of the rack portion 981 containing the rack portion teeth 983,thereby limiting the use of the ophthalmic device 210 to ten activations(e.g., ten pumps). For example, as shown in FIG. 13C, the rear seal 999on the rear end of the plunger 911 (e.g., the end closest to the inletport 931) may be configured to pop free after a set number ofactivations (e.g., three activations). This can prevent additionalsubstance added through the inlet port 931 from being retained in a boretube 913 (e.g., the substance reservoir) of the ophthalmic device 210.Further, the front end of the plunger 911 (e.g., the end closest to thetip segment 151) may include a one-way valve 915 (e.g., a duck valve), avalve retainer 917 and a front seal 919 (e.g., O-ring seal). The one-wayvalve 915 can provide for priming the ophthalmic device 210 whilepreventing backflow of the substance during priming and pumpingprocesses. Thus, the one-way valve 915 can seal the plunger 911 andprovide for further activations (e.g., seven or more) after the rearseal 999 pops off following the first three activations, providing for amaximum number of activations that can be used by the ophthalmic device210. Accordingly, the ophthalmic device 210 may be rendered unusableafter ten activations (e.g., pump actions) for health and safetyreasons, as well as to optimize the integrity of the device byminimizing wear of the components. For example, configuring theophthalmic device 210 to be disposable after a set number of useseliminates the need to clean/sterilize the device and avoids the issueof any of the seals 919, 999 drying up and failing.

FIGS. 14A-14C illustrate the priming process for an ophthalmic device10, 110, 210 in order to load the appropriate volume of substance (e.g.,viscoelastic fluid) and to clear the fluid path of the ophthalmic device10, 110, 210 of air. As shown in FIG. 14A, a syringe 1000 (e.g.,standard luer port syringe) containing the desired substance can becoupled to the inlet port 531, 831, 931 and the substance can then bepushed throughout the fluid path of the ophthalmic device 10, 110, 210until the substance comes out of the tip segment 151. The one-way valve915 allows the substance to flow through towards the tip segment 151while preventing any backflow of the substance back through the one-wayvalve 915. Once primed, the cannula 14 and the bore tube 913 can be fullof the desired volume of the substance, such as enough volume for tenpumping actions, for example.

As shown in FIG. 14B, the rear end of the plunger 911 is sealinglyengaged within the inlet port 531, 831, 931 via the rear seal 999. Therear end of the plunger 911 is shown in the starting position 950 (e.g.,before or after priming, but before any activations) in FIG. 14B. Duringeach activation (e.g., pumping action) of the ophthalmic device 10, 110,210, the plunger 911 advances away from the inlet port 531, 831, 931 asthe plunger 911 is moved forward the stroke length 970 for each pumpingcycle. After a set number of activations (e.g., three activations), therear end of the plunger 911 has advanced forward enough to separate ordisengage from a cylinder 995 of the ophthalmic device 10, 110, 210, asshown in FIG. 14C. For example, the rear seal 999 can pop off from asealing engagement with the interior of the cylinder 995, thuspreventing the ophthalmic device 10, 110, 210 from being able to bere-primed. At this point, the substance flow path can contain justenough substance for the remainder of the desired activations (e.g.,seven pumping actions). Accordingly, the ophthalmic device 10, 110, 210cannot be re-primed, refilled or used for more than the total number ofallowable pumping cycles (e.g., ten total pumping cycles).

FIGS. 15A and 15B illustrate an exemplary method of performing anophthalmic procedure using the ophthalmic device 10. The method can beused to deliver a substance (e.g., a fluid or gas) into, e.g., Schlemm'scanal 80 or any other suitable portion of a patient's eye.

As noted above, in a healthy eye, a stream of aqueous humor 82 drainsout of the anterior chamber 84 of the eye, through the trabecularmeshwork 86 and then into Schlemm's canal 80 and distal collectorchannels. The aqueous humor 82 then exits through Schlemm's canal 80into the collector channels and distal venous system. When this flowpath of aqueous humor 82 is interrupted (e.g., due to diseased ordamaged tissue in the trabecular meshwork 86 and/or Schlemm's canal 80),the IOP of an eye may rise, potentially resulting in a variety ofmedical concerns (e.g., glaucoma, loss of vision, optic nerve damage,etc.).

In order to improve the flow path of aqueous humor 82, a medicalprofessional may insert ocular component 21 through an incision 88 madein the anterior chamber 84 and advance the distal end of sleeve 260 ofthe ocular component 21 to the trabecular meshwork 86 so that it abutsagainst or contacts the trabecular meshwork 86. The sleeve 260 (notvisible in FIG. 15B) can then be retracted so that distal end of thecannula 14 including orifice(s) 32 enter the Schlemm's canal 80, asshown in FIG. 15B and as further described above using any of themechanisms or components described herein.

With reference to FIG. 15B, once distal end of cannula 14 is insertedinto Schlemm's canal 80 such that each of the one or more orifices 32 isfully housed within Schlemm's canal 80, the medical professional mayinject a pre-defined dose or amount of fluid or other substance viaactuation as discussed above. After injection of a pre-defined dose oramount of fluid or other substance through orifices 32, this process maybe repeated any appropriate number of times, with the cannula 14 held inthe same position and/or with the cannula 14 moved to one or moredifferent positions to inject fluid in different locations and/or fromdifferent angles. Optionally, after the injection of one or morepre-defined doses of fluid or other substance at a certain locationwithin Schlemm's canal 80, distal end of the cannula 14 may be retractedand repositioned within the eye. In some arrangements, suchrepositioning may occur via withdrawal of cannula 14 from incision 88(e.g., a first incision), and reinsertion through an additionalincision, spaced from the first incision. Additionally or alternatively,such repositioning may include retraction of distal end 30 fromSchlemm's canal 80 and/or trabecular meshwork 86 and then relocationinto a new portion of Schlemm's canal 80 without removal of cannula 14from the first incision 88. In some implementations, fluid may bedelivered into the Schlemm's canal 80 and trabecular meshwork 86simultaneously, causing the Schlemm's canal 80 to open and deliver thefluid into the various layers of the trabecular meshwork 86.

It is to be understood that while the foregoing description describesdevices and methods for injection of a fluid or other substance throughorifices 32, the ophthalmic device 10 described herein may be arrangedfor precision-controlled aspiration of fluid or other substances awayfrom the eye. For example, ophthalmic device 10 may be actuated in areverse manner from that described above to achieve a removal of fluidor other substances from the eye.

One or more embodiments of the subject technology may include anophthalmic device including a cannula having a cannula distal end, alumen, and one or more orifices coupled to the lumen, the cannulaconfigured to deliver a fluid; a sleeve disposed around the cannula andhaving a sleeve distal end; a handle coupled to the sleeve and thecannula, the handle having an actuator; and an internal mechanismcoupled to the actuator and configured to retract the sleeve relative tothe cannula. The internal mechanism may include a follower fixedlycoupled to the sleeve and moveable between distal and proximalpositions; and a release member movable between an activated positionand a release position, the release member coupled to the actuator andconfigured to release a force that urges the follower from the distalposition to the proximal position when the release member moves from theactivated position to the release position.

One or more embodiments of the subject technology may include whereinthe actuator includes a push button positioned on a lateral side of thehandle and moveable from an un-pressed position to a pressed positionupon application of a user force; and upon movement of the push buttonfrom the un-pressed position to the pressed position, the push button isconfigured to urge rotation of the release member in a first rotationaldirection.

One or more embodiments of the subject technology may include a resetspring coupled to the actuator, the reset spring configured to urge thepush button from the pressed position back to the un-pressed position tourge rotation of the release member in a second rotational directionopposite the first rotational direction.

One or more embodiments of the subject technology may include whereinthe cannula comprises a proximal shaft segment and a tip segmentattached to proximal shaft segment; and the one or more orifices aredisposed on the tip segment.

One or more embodiments of the subject technology may include a springcoupled to the follower and configured to apply a spring force to urgethe follower in the proximal direction when the follower is in thedistal position; a catch movable between a first position and a secondposition, the catch configured to hold the follower in the distalposition when the catch is in the first position and to release thefollower when the catch is in the second position; and the releasemember comprising a cam coupled to the catch, the cam configured torotate in a first rotational direction against the catch to urge thecatch from the first position to the second position.

One or more embodiments of the subject technology may include whereinthe cam is further coupled to the follower; the catch is biased towardsthe second position; and upon release of a user force, the catch isconfigured to urge the cam against the follower in a second rotationaldirection opposite to the first rotational direction to urge thefollower to from the proximal position to the distal position.

One or more embodiments of the subject technology may include a slidablehousing having one or more first magnets and one or more second magnets;and the release member comprising a rotatable housing having one or morethird magnets, wherein the slidable housing is configured to hold thefollower in the distal position when the one or more third magnets arealigned with the one or more first magnets, and to urge the follower tothe proximal position when the one or more third magnets are alignedwith the one or more second magnets.

One or more embodiments of the subject technology may include whereintwo first magnets are disposed 180 degrees apart in the slidable housingon a first plane that bisects a central axis of the slidable housing;two second magnets are disposed 180 degrees apart in the slidablehousing on a second plane that bisects a central axis of the slidablehousing; and two third magnets are disposed 180 degrees apart in therotatable housing on a third plane that bisects a central axis of therotatable housing.

One or more embodiments of the subject technology may include whereinthe rotatable housing is configured to align the one or more thirdmagnets with the one or more first magnets when the release member is inthe activated position; and the rotatable housing is configured to alignthe one or more third magnets with the one or more second magnets whenthe release member is in the release position.

One or more embodiments of the subject technology may include a springcoupled to the follower and configured to apply a spring force to urgethe follower in the proximal direction when the follower is in thedistal position; a dowel pin movable between a first position and asecond position, the dowel pin configured to hold the follower in thedistal position when the dowel pin is in the first position and torelease the follower when the dowel pin is in the second position; andthe release member comprising an arm coupled to the dowel pin, the armconfigured to rotate the dowel pin to urge the dowel pin from the firstposition to the second position.

One or more embodiments of the subject technology may include whereinthe dowel pin comprises two rounded portions and two flat portions,wherein one of the rounded portions is configured to abut a proximalsurface of the follower in the first position and one of the flatportions is configured to abut the proximal surface of the follower inthe second position.

One or more embodiments of the subject technology may include whereinthe dowel pin comprises an opening configured to receive the cannula,wherein the opening is configured to prevent the dowel pin fromcontacting the cannula during rotation of the dowel pin.

One or more embodiments of the subject technology may include theinternal mechanism further having a slidable housing having a proximalsurface comprising a first elevated portion and a first recessedportion; and the release member comprising a rotatable housing having adistal surface comprising a second elevated portion and a secondrecessed portion, wherein the slidable housing is configured to allowthe follower to be disposed in the distal position when the firstelevated portion is engaged with the second elevated portion, and tourge the follower to the proximal position when the first and secondelevated portions are engaged with the first and second recessedportions, respectively.

One or more embodiments of the subject technology may include a firstramp portion disposed between the first elevated portion and the firstrecessed portion, wherein the second elevated portion is configured toslide along the first ramp from the first elevated portion to the firstrecessed portion when the rotatable housing is moved from the activatedposition to the release position.

One or more embodiments of the subject technology may include a secondramp portion disposed between the second elevated portion and the secondrecessed portion, wherein the first elevated portion is configured toslide along the second ramp from the second elevated portion to thesecond recessed portion when the rotatable housing is moved from theactivated position to the release position.

One or more embodiments of the subject technology may include theinternal mechanism further having a gap disposed between a distal facingsurface of the follower and a proximal facing surface of the slidablehousing when the follower is disposed in the distal position; and aspring coupled to the slidable housing and configured to apply a springforce to urge the slidable housing in the proximal direction when thefollower is in the distal position, wherein the spring force isconfigured to cause the distal facing surface of the follower toaccelerate through the gap and contact the proximal facing surface ofthe slidable housing with an impact force.

One or more embodiments of the subject technology may include whereinthe spring force is configured to cause the sleeve to move backward at avelocity of 0.3-0.5 in/sec.

One or more embodiments of the subject technology may include a damperspring disposed proximally to the follower, the damper spring configuredto dampen an impact force from the follower when the follower is movedto the proximal position and to bias the follower towards the distalposition when the follower is in the proximal position.

One or more embodiments of the subject technology may include whereinthe rotatable housing is configured to rotate 45 degrees in a firstrotational direction about a central longitudinal axis of the cannulawhen the rotatable housing moves from the activated position to therelease position.

One or more embodiments of the subject technology may include Aninternal mechanism for an ophthalmic device, the internal mechanismincluding: a slidable follower configured to be fixedly coupled to asleeve disposed around a cannula, the slidable follower moveable betweendistal and proximal positions along a central longitudinal axis; aslidable housing having a proximal surface comprising a first elevatedportion and a first recessed portion; a rotatable housing having adistal surface comprising a second elevated portion and a secondrecessed portion, the rotatable housing configured to be coupled to anactuator and movable between an activated position and a releaseposition, wherein the first elevated portion is engaged with the secondelevated portion in the activated position and the second elevatedportion is engaged with the first recessed portion in the releaseposition; a gap disposed between a distal facing surface of the followerand a proximal facing surface of the slidable housing when the followeris disposed in the distal position; and a spring coupled to the slidablehousing and configured to apply a spring force to urge the slidablehousing in the proximal direction when the follower is in the distalposition, wherein the spring force is configured to cause the distalfacing surface of the follower to accelerate through the gap and contactthe proximal facing surface of the slidable housing with an impactforce.

While principles of the present disclosure are described herein withreference to illustrative embodiments for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications,embodiments, and substitution of equivalents all fall within the scopeof the embodiments described herein. Accordingly, the invention is notto be considered as limited by the foregoing description.

A reference to an element in the singular is not intended to mean oneand only one unless specifically so stated, but rather one or more. Forexample, “a” module may refer to one or more modules. An elementproceeded by “a,” “an,” “the,” or “said” does not, without furtherconstraints, preclude the existence of additional same elements.

Headings and subheadings, if any, are used for convenience only and donot limit the invention. The word exemplary is used to mean serving asan example or illustration. To the extent that the term include, have,or the like is used, such term is intended to be inclusive in a mannersimilar to the term comprise as comprise is interpreted when employed asa transitional word in a claim. Relational terms such as first andsecond and the like may be used to distinguish one entity or action fromanother without necessarily requiring or implying any actual suchrelationship or order between such entities or actions.

Phrases such as an aspect, the aspect, another aspect, some aspects, oneor more aspects, an implementation, the implementation, anotherimplementation, some implementations, one or more implementations, anembodiment, the embodiment, another embodiment, some embodiments, one ormore embodiments, a configuration, the configuration, anotherconfiguration, some configurations, one or more configurations, thesubject technology, the disclosure, the present disclosure, othervariations thereof and alike are for convenience and do not imply that adisclosure relating to such phrase(s) is essential to the subjecttechnology or that such disclosure applies to all configurations of thesubject technology. A disclosure relating to such phrase(s) may apply toall configurations, or one or more configurations. A disclosure relatingto such phrase(s) may provide one or more examples. A phrase such as anaspect or some aspects may refer to one or more aspects and vice versa,and this applies similarly to other foregoing phrases.

A phrase “at least one of” preceding a series of items, with the terms“and” or “or” to separate any of the items, modifies the list as awhole, rather than each member of the list. The phrase “at least one of”does not require selection of at least one item; rather, the phraseallows a meaning that includes at least one of any one of the items,and/or at least one of any combination of the items, and/or at least oneof each of the items. By way of example, each of the phrases “at leastone of A, B, and C” or “at least one of A, B, or C” refers to only A,only B, or only C; any combination of A, B, and C; and/or at least oneof each of A, B, and C.

It is understood that the specific order or hierarchy of steps,operations, or processes disclosed is an illustration of exemplaryapproaches. Unless explicitly stated otherwise, it is understood thatthe specific order or hierarchy of steps, operations, or processes maybe performed in different order. Some of the steps, operations, orprocesses may be performed simultaneously. The accompanying methodclaims, if any, present elements of the various steps, operations orprocesses in a sample order, and are not meant to be limited to thespecific order or hierarchy presented. These may be performed in serial,linearly, in parallel or in different order. It should be understoodthat the described instructions, operations, and systems can generallybe integrated together in a single software/hardware product or packagedinto multiple software/hardware products.

In one aspect, a term coupled or the like may refer to being directlycoupled. In another aspect, a term coupled or the like may refer tobeing indirectly coupled.

Terms such as top, bottom, front, rear, side, horizontal, vertical, andthe like refer to an arbitrary frame of reference, rather than to theordinary gravitational frame of reference. Thus, such a term may extendupwardly, downwardly, diagonally, or horizontally in a gravitationalframe of reference.

The disclosure is provided to enable any person skilled in the art topractice the various aspects described herein. In some instances,well-known structures and components are shown in block diagram form inorder to avoid obscuring the concepts of the subject technology. Thedisclosure provides various examples of the subject technology, and thesubject technology is not limited to these examples. Variousmodifications to these aspects will be readily apparent to those skilledin the art, and the principles described herein may be applied to otheraspects.

All structural and functional equivalents to the elements of the variousaspects described throughout the disclosure that are known or later cometo be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112(f), unless the element isexpressly recited using the phrase “means for” or, in the case of amethod claim, the element is recited using the phrase “step for”.

The title, background, brief description of the drawings, abstract, anddrawings are hereby incorporated into the disclosure and are provided asillustrative examples of the disclosure, not as restrictivedescriptions. It is submitted with the understanding that they will notbe used to limit the scope or meaning of the claims. In addition, in thedetailed description, it can be seen that the description providesillustrative examples and the various features are grouped together invarious implementations for the purpose of streamlining the disclosure.The method of disclosure is not to be interpreted as reflecting anintention that the claimed subject matter requires more features thanare expressly recited in each claim. Rather, as the claims reflect,inventive subject matter lies in less than all features of a singledisclosed configuration or operation. The claims are hereby incorporatedinto the detailed description, with each claim standing on its own as aseparately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage of the claims and to encompass all legal equivalents.Notwithstanding, none of the claims are intended to embrace subjectmatter that fails to satisfy the requirements of the applicable patentlaw, nor should they be interpreted in such a way.

What is claimed is:
 1. An ophthalmic device comprising: a cannula havinga cannula distal end, a lumen, and one or more orifices coupled to thelumen, the cannula configured to deliver a fluid; a sleeve disposedaround the cannula and having a sleeve distal end; a handle coupled tothe sleeve and the cannula at a handle distal end, the handle having anactuator; a reset spring coupled to the actuator, the reset springconfigured to urge a push button of the actuator from a pressed positionback to an un-pressed position; an internal mechanism coupled to theactuator and configured to pump the fluid, the internal mechanismcomprising: an inlet port disposed on a handle proximal end; a drivemember coupled to the actuator, wherein: the drive member is a drivegear comprising a plurality of drive gear teeth; the drive gear isengaged with a rack portion of a plunger, the rack portion comprising aplurality of rack portion teeth; and rotation of the drive gear in adrive rotational direction causes the plunger to advance in a distaldirection; the plunger coupled to the drive member, wherein the drivemember is configured to provide a force that moves the plunger in adistal direction along a longitudinal axis of the handle when theactuator moves from an un-pressed position to a pressed position, themovement of the plunger causing the fluid to move distally through thehandle and the cannula, and a portion of the fluid to exit the one ormore orifices; and a trigger gear coupled to the drive gear via a driveaxle, wherein: the trigger gear comprises a plurality of trigger gearteeth; the actuator comprises a plurality of actuator teeth; andmovement of the push button to the pressed position comprises rotationof the push button about an actuator axle, causing the actuator teeth tomove along the trigger gear teeth and move the trigger gear in the driverotational direction, the movement of the trigger gear causing the drivegear to also move in the drive rotational direction via the drive axle.2. The ophthalmic device of claim 1, wherein: the actuator includes apush button positioned on the handle and is moveable from the un-pressedposition to the pressed position upon application of a user force; andupon movement of the push button from the un-pressed position to thepressed position, the push button is configured to urge rotation of thedrive member in a drive rotational direction.
 3. The ophthalmic deviceof claim 1, wherein: the sleeve is operationally coupled to theactuator; and the rotation of the push button about the actuator axlecauses the sleeve to retract from the cannula distal end so that thefluid is delivered to the cannula distal end while the sleeve is in aretracted proximal position.
 4. The ophthalmic device of claim 1, theinternal mechanism further comprising a one-way clutch coupled to thetrigger gear and configured to provide engagement of the trigger gearwith the drive axle in an indexing configuration, wherein duringmovement of the push button back to the un-pressed position, the one-wayclutch is configured to disengage the trigger gear from the drive axleto allow the trigger gear to rotate in a direction opposite to the driverotational direction without further movement of the drive axle and thedrive gear.
 5. The ophthalmic device of claim 1, the internal mechanismfurther comprising: a bore tube coupled to a distal end of the plunger;and a front seal coupled to a distal end of the plunger, the front sealconfigured to prevent backflow of the fluid in a proximal directionthrough the bore tube.
 6. The ophthalmic device of claim 1, the internalmechanism further comprising a one-way valve coupled to a distal end ofthe plunger, the one-way valve configured to allow fluid flow in thedistal direction during priming actions, and to prevent backflow of thefluid past the distal end of the plunger in the proximal direction. 7.The ophthalmic device of claim 1, the internal mechanism furthercomprising a rear seal coupled to a proximal end of the plunger, therear seal configured to prevent fluid from leaking out of the plungerwhen the device is being primed.
 8. The ophthalmic device of claim 7,the internal mechanism further comprising a cylinder coupled to theinlet port, the cylinder configured to slidingly receive the proximalend of the plunger.
 9. The ophthalmic device of claim 8, wherein: theproximal end of the plunger is configured to slide within the cylinderin the distal direction during each press of the push button; and therear seal is configured to disengage from a sealing engagement with thecylinder after a set number of push button presses, preventing theophthalmic device from being able to be re-primed.
 10. The ophthalmicdevice of claim 9, wherein the ophthalmic device is configured to retaina volume of fluid after disengagement of the rear seal from thecylinder, wherein the retained volume of fluid is dispensed after aremaining set number of button pushes.
 11. An internal mechanism for anophthalmic device, the internal mechanism comprising: an inlet port; aplunger, the plunger having a rack portion comprising a plurality ofrack portion teeth; a drive gear comprising a plurality of drive gearteeth, the drive gear engaged with the rack portion of the plunger; atrigger gear coupled to the drive gear via a drive axle, the triggergear comprising a plurality of trigger gear teeth configured to engagewith a plurality of actuator teeth of an actuator; and a reset springconfigured to urge a push button of the actuator from a pressed positionto an un-pressed position; wherein the trigger gear is configured torotate in a first rotational direction from an activation movement ofthe actuator comprising rotation of the push button about an actuatoraxle causing the actuator teeth to move along the trigger gear teeth,wherein the drive gear is configured to rotate in the first rotationaldirection via the drive axle coupled to the trigger gear and to providea force on the rack portion of the plunger that moves the plunger in afirst linear direction, wherein the movement of the plunger in the firstlinear direction causes a fluid to pump through the ophthalmic device.12. The internal mechanism of claim 11, further comprising a one-wayclutch coupled to the trigger gear, the one-way clutch configured to:engage the trigger gear with the drive axle during the activationmovement of the actuator; and disengage the trigger gear from the driveaxle during a reset movement of the actuator to allow the trigger gearto rotate in a direction opposite to the first rotational directionwithout further movement of the drive axle, the drive gear and theplunger.